Complete DEScover dataset demonstrates 92.7% overall TLPP and 79.9% overall ACPP at six months, with primary safety endpoint met
DALLAS, TX, UNITED STATES, September 8, 2026 /EINPresswire.com/ — ANVISA approves new 40-patient DEScover arm evaluating an intermediate sirolimus dose across longer uncovered stent-edge segments
Solaris Endovascular, Inc., a growth-stage medical technology company advancing next-generation covered stent technologies, today announced complete 6-month results from the DEScover Phase II study evaluating the investigational Solaris DE sirolimus-eluting covered stent for dialysis access dysfunction. The results were presented at CIRSE 2026 in Copenhagen by Leonardo Harduin, MD, Principal Investigator of DEScover.
At six months, Solaris DE demonstrated exceptional patency across both arteriovenous fistula (AVF) and arteriovenous graft (AVG) patients, with results exceeding those previously reported with conventional covered stents and balloon-based therapies. The study also met its primary safety endpoint:
– 92.7% Overall Target Lesion Primary Patency (TLPP) with Solaris DE
– 92.0% TLPP with Solaris DE vs. 65.9% with PTA in the randomized AVF cohort
– 93.5% TLPP in the AVG cohort
– 79.9% Overall Access Circuit Primary Patency (ACPP) with Solaris DE
– 81.3% ACPP with Solaris DE vs. 65.9% with PTA in the randomized AVF cohort
– 78.1% ACPP in the AVG cohort
– Primary safety endpoint met, with 97.3% freedom from access- or venous outflow circuit-related safety events at 30 days
“The complete 6-month results are extremely exciting,” said Leonardo Harduin, MD, Principal Investigator of DEScover and vascular surgeon at the State University of Rio de Janeiro (UERJ). “The high TLPP demonstrates a compelling treatment effect at the target lesion, while the ACPP results demonstrate the potential to preserve functioning dialysis access and reduce the need for repeat intervention. Solaris DE has the potential to transform dialysis access care and meaningfully reduce the burden of repeat interventions for patients.”
Solaris DE represents a new therapeutic category in vascular access, combining three synergistic technologies designed to support durable patency: a self-expanding nitinol scaffold engineered for precise deployment and durability; a next-generation electrospun-PTFE membrane that provides a structural barrier to neointimal cell migration; and controlled sirolimus delivery at the uncovered stent edges to inhibit smooth-muscle proliferation and address edge restenosis. Solaris DE received Breakthrough Device Designation from the FDA on May 1, 2026, for the treatment of stenosis within the dialysis outflow circuit at the venous anastomosis of synthetic arteriovenous grafts.
Building on the encouraging DEScover results, Solaris Endovascular received ANVISA approval in Brazil for a fourth, 40-patient, single-arm AVF cohort evaluating an intermediate sirolimus dose across longer uncovered stent-edge segments. The total drug dose will be approximately 2.7x the initial dose while remaining well within sirolimus’ broad therapeutic window. The new arm will evaluate the potential clinical benefit of extending sirolimus delivery across a longer portion of the uncovered stent-edge segments.
“The complete 6-month results strengthen our conviction that Solaris DE could redefine the treatment of dialysis access dysfunction,” said Dr. Marco Costa, Chief Scientific & Medical Officer of Solaris Endovascular. “With compelling clinical data, a differentiated therapeutic approach, Breakthrough Device Designation, and an expanding development program, we believe Solaris Endovascular is well positioned to advance toward FDA IDE approval and initiation of a U.S. pivotal study for the Solaris DE combination product.”
About DEScover
DEScover is a prospective, multicenter Phase II feasibility study evaluating Solaris DE in patients with failing hemodialysis access circuits. The original 120-patient study enrolled 80 patients with AVF, randomized 1:1 to Solaris DE or percutaneous transluminal angioplasty (PTA), and 40 patients with AVG treated with Solaris DE in a single-arm cohort. The study’s primary endpoints evaluate safety at 30 days and TLPP at six months, with additional patency and safety outcomes assessed through 24 months. The study is being expanded with an additional 40-patient, single-arm AVF cohort evaluating an intermediate sirolimus dose across longer uncovered stent-edge segments.
About Solaris Endovascular
Solaris Endovascular, Inc. is a U.S.-based growth-stage medical technology company developing and commercializing next-generation endovascular covered stent technologies for patients with dialysis access dysfunction and peripheral artery disease. Its portfolio includes Solaris SX, a self-expanding electrospun-PTFE covered stent marketed outside the U.S., and Solaris DE, an investigational sirolimus-eluting covered stent designed to address edge restenosis, a persistent limitation of current covered stent therapy.
Building on its proven covered stent platform and innovative drug-eluting technology, Solaris Endovascular is committed to advancing vascular care and improving long-term patient outcomes.
Solaris DE is an investigational device and is not approved for commercial sale anywhere in the world.
Randolph Hubbell
Solaris Endovascular, Inc
+1 215-688-6196
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